UK: The Science Of Biopharmaceutical Innovation – Is Targeting A Win-Win For Everyone Concerned?

Innovating in the biopharmaceutical field is becoming more and
more challenging. Our recent
report, in conjunction with Thomson Reuters, clearly shows that
some companies are successfully dealing with the current
environment, while others are struggling to innovate. One of the
key themes to come out of last week's FT Global Pharmaceuticals
and Biotechnology Conference was the need to shift from
a therapy area focus to a focus on science – identifying
specific pathways and targets, whether these be proteomic or
epigenetic . This means first developing an understanding of the
science of a specific biological pathway and then identifying
the therapeutic areas that can be targeted through manipulation of
this pathway. Many of the speakers highlighted how important
targeting is becoming for any new life sciences drug; targeting the
right science, targeting the right patients and targeting
outcomes.

When it comes to targeting the right science, success in
treating certain cancers is increasingly down to the ability of
researchers to identify appropriate genetic or protein targets and
subsequently develop therapies which interact with those targets to
prevent disease onset or disease progression. One Nature Review
paper highlighted at the conference examined factors driving
R&D success and demonstrated that therapeutic areas are not in
themselves a driver of success. The paper cites infectious
diseases, on which a large amount of research has been focussed, as
a positive indicator of success. In contrast a focus on
neuroscience, which remains a poorly understood area of scientific
research, was seen to exert a negative influence. What
appeared to make the most difference was scientific acumen and good
judgement, particularly with respect to earlier terminations and
initiating proof of concept promptly.

In terms of targeting the right patients this has two key
implications for the industry. Firstly, targeting the right
patients typically means a companion diagnostic will be required.
This involves not only identifying an appropriate therapeutic
target, but ensuring that it is possible to identify a diagnostic
marker for which a test can be developed.

The second implication of targeting specific patients is in
terms of potential revenue generation. Targeting a discrete
population of potential responders will likely mean lower volumes
of patients. However, the upside for all stakeholders (the
industry, regulators, payers, patients and physicians) is that
patient outcomes are optimised and resources (money and time) are
not wasted on patients who fail to respond.

The development of personalised medicines provides an
opportunity for the industry and regulators to explore new ways of
collaborating, which could benefit everyone. Furthermore, such
therapies typically target areas of high unmet need, for which
there is either no current treatment or treatments that fail to
deliver effective results.

Targeting outcomes refers to utilising the vast amount of
available real world data to track treatment response and provide
insight into the clinical and social benefits offered by medicines.
Ultimately this will aid in demonstrating the value of medicines
and approval of reimbursement relative to this. Unlocking the
potential of targeted outcomes requires the healthcare system to
shift towards a more transparent and collaborative data sharing
model, which will provide mutual benefit to all.

A number of speakers at the conference gave fascinating insights
into the importance of following the science. These included
breaking down internal divisions to ensure that pharmaceutical
researchers and diagnostics experts can work together in an
intellectual property (IP)-free environment, enabling R&D teams
to look at therapeutic targets from a combined drug and diagnostic
stance. Another approach was to simplify the organisational
structure, change the attitudes of staff and develop much closer
links to academia, creating innovation hubs which bring the company
closer to science.

There was a lot of discussion at the conference about
risk-sharing models, specifically around the area of adaptive
licensing. Such mechanisms would allow innovative therapies to be
launched earlier into the market, as long as agreement can be
reached around potential risk, availability and pricing. The
advantages to the industry include:

gaining earlier marketing authorisation

the ability to collect real world evidence by obtaining timely
feedback on a therapy's impact in the real world setting as
opposed to using controlled clinical trials

sharing risk with regulators

removing the need for expensive and time-consuming late stage
trials

generating returns earlier in the development lifecycle

more rapid uptake of innovation.

The advantages for patients, payers and regulators include:

earlier access to innovative new medicines

flexibility around pricing – the idea being as part of
the risk-share, drugs are launched at a lower price

real world data which is more reflective of patient outcomes is
collected earlier

the true value of the drug becomes apparent earlier.

Overall this suggests that the direction of travel for
biopharmaceutical innovation should be a win-win for everyone
concerned.

The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.

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